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|Exenatide

EXENATIDE (Systemic)†

Some commonly used brand names are:

In the U.S.—

• Byetta

† Not commercially available in Canada.

Category

• Antidiabetic agent

Description

Exenatide ((ex-EN-a-tide)) injection is used to treat high blood sugar levels that are caused by a type of diabetes mellitus or sugar diabetes called type 2 diabetes. Normally, after you eat, your pancreas releases insulin to help your body store excess sugar for later use. This process occurs during normal digestion of food. In type 2 diabetes, your body does not work properly to store the excess sugar and the sugar remains in your bloodstream. Chronic high blood sugar can lead to serious health problems in the future. Proper diet is the first step in managing type 2 diabetes but often medicines are needed to help your body. Exenatide helps your body cope with high blood sugar in several ways. Exenatide helps the cells in the pancreas that produce insulin when there is too much sugar in your blood. Exenatide helps the cells of your liver to decrease the amount of sugar the liver dumps into your blood. Exenatide slows down the passage of food from your stomach and helps to decrease the amount of sugar added to your blood after eating. Exenatide also reduces the amount of food needed because the sugar in the bloodstream is processed more effectively.

This medicine is available only with your doctor"s prescription, in the following dosage forms:

• Injection (U.S.)

Before Using This Medicine

In deciding to use a medicine, the risks of using the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For exenatide, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to exenatide. Also tell your doctor and pharmacist if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Exenatide has not been studied in pregnant women. However, studies in animals have shown that exenatide can cause birth defects. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding—It is not known whether exenatide passes into the breast milk. Because exenatide has been shown to cause adverse effects in animals, it is not recommended during breast-feeding.

Children—Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of exenatide in children with use in other age groups.

Older adults—This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your health care professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other medical problems—The presence of other medical problems may affect the use of exenatide. Make sure you tell your doctor if you have any other medical problems, especially:

• Diabetic ketoacidosis or
• Type 1 diabetes— These conditions should be treated with insulin.

• Gastrointestinal disease, severe or
• Kidney disease, end-stage— May make symptoms such as nausea, diarrhea, and vomiting worse

• Liver disease— Use with caution

Proper Use of This Medicine

Dosing—The dose of exenatide will be different for different patients. Follow your doctor"s orders or the directions on the label . The following information includes only the average doses of exenatide. If your dose is different, do not change it unless your doctor tells you to do so.

• For subcutaneous dosage form (injection):
  • For type 2 diabetes:
    • Adults—At first, your dose will be an injection to the thigh, upper arm, or stomach of 5 mcg two times a day at any time within the 60-minute period before the morning and evening meals. Your doctor may adjust your dose after the first month of therapy to 10 mcg twice a day.
    • Children—Use and dose must be determined by your doctor.

Missed dose—If you miss a dose of exenatide, wait until the next scheduled dose to resume therapy.

Storage—To store this medicine:

• Store in the refrigerator. However, keep the medicine from freezing.
• Do not keep outdated medicine or medicine no longer needed. Ask your health care professional how you should dispose of any medicine you do not use. Be sure that any discarded medicine is out of the reach of children. The pen should be discarded 30 days after the first time it is used.

Precautions While Using This Medicine

Your doctor will want to check your progress at regular visits , .

It is very important to follow carefully any instructions from your health care team about :

• Alcohol—Drinking alcohol may cause severe low blood sugar. Discuss this with your health care team.
• Other medicines—Do not take other medicines during the time you are taking exenatide unless they have been discussed with your doctor. This especially includes nonprescription medicines such as aspirin, and medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems.
• Counseling—Other family members need to learn how to prevent side effects or help with side effects if they occur. Also, diabetic patients may need special counseling about diabetes medicine dosing changes that might occur because of lifestyle changes, such as changes in exercise and diet. Furthermore, counseling on contraception and pregnancy may be needed because of the problems that can occur in patients with diabetes during pregnancy.
• Travel—Keep a recent prescription and your medical history with you. Be prepared for an emergency as you would normally. Make allowances for changing time zones and keep your meal times as close as possible to your usual meal times.

In case of emergency —There may be a time when you need emergency help for a problem caused by your diabetes. You need to be prepared for these emergencies. It is a good idea to wear a medical identification (ID) bracelet or neck chain at all times. Also, carry an ID card in your wallet or purse that says that you have diabetes and a list of all of your medicines.

This medicine does not cause hypoglycemia (low blood sugar). However, low blood sugar can occur when exenatide is taken with other medicines, such as insulin or sulfonylureas, that can lower blood sugar. Low blood sugar can also occur if you delay or miss a meal or snack, exercise more than usual, drink alcohol, or cannot eat because of nausea or vomiting.

Symptoms of low blood sugar include anxiety; behavior change similar to being drunk; blurred vision; cold sweats; confusion; cool, pale skin; difficulty in thinking; drowsiness; excessive hunger; fast heartbeat; headache (continuing); nausea; nervousness; nightmares; restless sleep; shakiness; slurred speech; or unusual tiredness or weakness.

If symptoms of low blood sugar occur, eat glucose tablets or gel, corn syrup, honey, or sugar cubes; or drink fruit juice, nondiet soft drink, or sugar dissolved in water to relieve the symptoms. Also, check your blood for low blood sugar. Glucagon is used in emergency situations when severe symptoms such as seizures (convulsions) or unconsciousness occur . Have a glucagon kit available, along with a syringe and needle, and know how to use it. Members of your family also should know how to use it.

Hyperglycemia (high blood sugar) may occur if you do not take enough or skip a dose of your antidiabetic medicine, overeat or do not follow your meal plan, have a fever or infection, or do not exercise as much as usual.

Symptoms of high blood sugar include blurred vision; drowsiness; dry mouth; flushed, dry skin; fruit-like breath odor; increased urination (frequency and amount); ketones in urine; loss of appetite; stomachache, nausea, or vomiting; tiredness; troubled breathing (rapid and deep); unconsciousness; or unusual thirst.

If symptoms of high blood sugar occur, check your blood sugar level and then call your doctor for instructions .

Side Effects of This Medicine

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Developed: 07/14/2005

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